A Phase 4 interventional study of Vaxelis™ in Vaccines, Combined and Hexavalent Vaccine, sponsored by Merck Sharp & Dohme LLC. Completed at 13 sites in 3 countries. Open to participants aged 11 Months to 13 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-29.
Sponsored by Merck Sharp & Dohme LLC · Phase 4, Interventional, and Prevention
The primary objectives of this study are to evaluate the safety, tolerability, and immunogenicity of a booster dose of Vaxelis™ (V419) given at \~11 to 13 months of age in healthy participants who were previously vaccinated with a 2-dose primary infant series of either Vaxelis™ or Hexyon™.
Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.
Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants who received a 2-dose regimen of Vaxelis™ as infants prior to enrollment will receive a Vaxelis™ booster at \~11 months of age.
Biological: Vaxelis™
Participants who received a 2-dose regimen of Hexyon™ as infants prior to enrollment will receive a Vaxelis™ booster at \~11 months of age.
Biological: Vaxelis™
Vaxelis™ 0.5 mL sterile suspension in prefilled syringe for intramuscular administration.
Also known as: V419
Percentage of Participants With a Solicited Injection-site Adverse Event (AE)
Solicited injection-site AEs are predefined local (at the injection/administration site) events for which the participant's legally authorized representative was specifically questioned. Participant's legally acceptable representative used a Vaccination Report Card (VRC) to report the following solicited injection-site AEs : swelling, redness (erythema), and pain/tenderness. 95% confidence intervals (CIs) were calculated based on the exact binomial method proposed by Clopper and Pearson.
Time frame: Up to 5 days postvaccination
Percentage of Participants With a Solicited Systemic AE
Solicited systemic AE are predefined systemic events for which the participant's legally authorized representative was specifically questioned. Participant's legally acceptable representative used a VRC to report the following solicited systemic AEs: vomiting, drowsiness (somnolence), loss of appetite, and irritability. 95% CIs were calculated based on the exact binomial method proposed by Clopper and Pearson.
Time frame: Up to 5 days postvaccination
Percentage of Participants With Unsolicited AEs
An unsolicited AE is an AE that was not solicited using a VRC and that is communicated by a participant's legally authorized representative who has signed the informed consent. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. 95% CIs were calculated based on the exact binomial method proposed by Clopper and Pearson.
Time frame: Up to 15 days postvaccination
Percentage of Participants With a Serious AE (SAE)
An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is another important medical event. 95% CIs were calculated based on the exact binomial method proposed by Clopper and Pearson.
Time frame: Up to 40 days postvaccination
Percentage of Participants With Diphtheria Toxoid Antibodies ≥0.1 IU/mL
Human antibodies to diphtheria toxoid were quantified using the Meso Scale Discovery Electrochemiluminescence serological assay based on an established reference standard sample curve with the lower limit of quantitation (LLOQ) for diphtheria antibody of 0.005 IU/mL. The percentage of participants with diphtheria toxoid antibodies ≥0.1 international units per milliliter (IU/mL) one month after Vaxelis™ as the 3rd dose of a vaccination series is presented. The 95% CIs are based on the exact binomial method proposed by Clopper and Pearson.
Time frame: 30 days postvaccination (at ~12 months of age)
Percentage of Participants With Tetanus Toxoid Antibodies ≥0.1 IU/mL
Human antibodies to tetanus toxoid were quantified using the Meso Scale Discovery Electrochemiluminescence serological assay based on an established reference standard sample curve with a LLOQ for tetanus antibody of 0.01 IU/mL. The percentage of participants with tetanus toxoid antibodies ≥0.1 IU/mL one month after Vaxelis™ as the 3rd dose of a vaccination series is presented. The 95% CIs are based on the exact binomial method proposed by Clopper and Pearson.
Time frame: 30 days postvaccination (at ~12 months of age)
Percentage of Participants With Pertussis Toxoid (PT) Vaccine Response
Human antibodies to pertussis toxoid were quantified using the Meso Scale Discovery Electrochemiluminescence serological assay based on an established reference standard sample curve with a LLOQ for pertussis antibody of 2.00 EU/mL. The percentage of participants meeting response criteria for PT is based on pre-vaccination level of PT is presented. The 95% CIs are based on the exact binomial method proposed by Clopper and Pearson.
Time frame: 30 days postvaccination (at ~12 months of age)
Percentage of Participants With Filamentous Hemagglutinin (FHA) Vaccine Response
Human antibodies to FHA were quantified using the Meso Scale Discovery Electrochemiluminescence serological assay based on an established reference standard sample curve with a LLOQ for FHA antibody of 2.00 EU/mL. The percentage of participants meeting response criteria for FHA response will be based on pre-vaccination level of FHA. The 95% CIs are based on the exact binomial method proposed by Clopper and Pearson.
Time frame: 30 days postvaccination (at ~12 months of age)
Percentage of Participants With Haemophilus Influenzae Type b Polyribosylribitol Phosphate (Hib-PRP) Antibodies ≥1.0 µg/mL
Human antibodies to Hib-PRP were quantified using the Vacczyme™ Human Anti-Haemophilus influenzae Type b Enzyme Immunoassay Kit. Levels of anti-Hib IgG were quantified by interpolation from a standard curve that has been calibrated to the FDA lot 1983 reference serum. The percentage of participants with Hib-PRP antibodies ≥0.1 IU/mL one month after Vaxelis™ as the 3rd dose of a vaccination series is presented. The 95% CIs are based on the exact binomial method proposed by Clopper and Pearson.
Time frame: 30 days postvaccination (at ~12 months of age)
Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Antibodies ≥10 mIU/mL
Human antibodies to HBsAg were quantified using an Enhanced Chemiluminescence (ECi) assay, with the hepatitis B WHO International reference standard at 10 mIU/mL as a control in every assay, and the LLOQ of the assay is 5 mIU/mL. The percentage of participants with HBsAg antibodies ≥10 milli-international per liter (mIU/mL) one month after Vaxelis™ as the 3rd dose of a vaccination series is presented. The 95% CIs are based on the exact binomial method proposed by Clopper and Pearson.
Time frame: 30 days postvaccination (at ~12 months of age)
Percentage of Participants With Poliovirus Serotype 1 Neutralizing Antibodies (Nab) ≥1:8 Dilution
Human antibodies to poliovirus serotype 1 were quantified with a neutralization assay by utilizing Vero cells and wild type poliovirus strain 1 as the challenge virus. The Karber method was used to determine the serum dilution that neutralized 50% of the challenge virus, with results expressed as titers (1:dilution), and the LLOQ was 1:4. dilution. The percentage of participants with poliovirus serotype 1 Nab ≥1:8 dilution one month after Vaxelis™ as the 3rd dose of a vaccination series is presented. The 95% CIs are based on the exact binomial method proposed by Clopper and Pearson.
Time frame: 30 days postvaccination (at ~12 months of age)
Percentage of Participants With Poliovirus Serotype 2 Neutralizing Antibodies (Nab) ≥1:8 Dilution
Human antibodies to poliovirus serotype 2 were quantified with a neutralization assay by utilizing Vero cells and wild type poliovirus strain 2 as the challenge virus. The Karber method was used to determine the serum dilution that neutralized 50% of the challenge virus, with results expressed as titers (1:dilution), and the LLOQ was 1:4. dilution. The percentage of participants with poliovirus serotype 2 Nab ≥1:8 dilution one month after Vaxelis™ as the 3rd dose of a vaccination series is presented. The 95% CIs are based on the exact binomial method proposed by Clopper and Pearson.
Time frame: 30 days postvaccination (at ~12 months of age)
Percentage of Participants With Poliovirus Serotype 3 Neutralizing Antibodies (Nab) ≥1:8 Dilution
Human antibodies to poliovirus serotype 3 were quantified with a neutralization assay by utilizing Vero cells and wild type poliovirus strain 3 as the challenge virus. The Karber method was used to determine the serum dilution that neutralized 50% of the challenge virus, with results expressed as titers (1:dilution), and the LLOQ was 1:4. dilution. The percentage of participants with poliovirus serotype 3 Nab ≥1:8 dilution one month after Vaxelis™ as the 3rd dose of a vaccination series is presented. The 95% CIs are based on the exact binomial method proposed by Clopper and Pearson.
Time frame: 30 days postvaccination (at ~12 months of age)
Percentage of Participants With Pertactin (PRN) Vaccine Response
Human antibodies to PRN were quantified using the Meso Scale Discovery Electrochemiluminescence serological assay based on an established reference standard sample curve with a LLOQ for PRN of 2.00 EU/mL.The percentage of participants meeting response criteria for PRN was based on pre-vaccination level of PRN. The 95% CIs are based on the exact binomial method proposed by Clopper and Pearson.
Time frame: 30 days postvaccination (at ~12 months of age)
Percentage of Participants With Fimbriae 2/3 (FIM 2/3) Vaccine Response
Human antibodies to FIM 2/3 were quantified using the Meso Scale Discovery Electrochemiluminescence serological assay based on an established reference standard sample curve with a LLOQ for pertussis antibody of 2.00 EU/mL. The percentage of participants meeting response criteria for FIM 2/3 was based on pre-vaccination level of FIM 2/3. The 95% CIs are based on the exact binomial method proposed by Clopper and Pearson.
Time frame: 30 days postvaccination (at ~12 months of age)
Healthy participants approximately 11 to 13 months of age, (≥327 days to ≤396 days inclusive).were enrolled in this study.
| Milestone | Group 1: V, V, V | Group 2: H, H, V |
|---|---|---|
| Started | 86 | 82 |
| Treated | 85 | 82 |
| Completed | 85 | 82 |
| Not completed | 1 | 0 |
| Withdrew: Mistakenly allocated, untreated | 1 | 0 |
Solicited injection-site AEs are predefined local (at the injection/administration site) events for which the participant's legally authorized representative was specifically questioned. Participant's legally acceptable representative used a Vaccination Report Card (VRC) to report the following solicited injection-site AEs : swelling, redness (erythema), and pain/tenderness. 95% confidence intervals (CIs) were calculated based on the exact binomial method proposed by Clopper and Pearson.
| Percentage of participants | Group 1: V, V, V | Group 2: H, H, V |
|---|---|---|
| Injection site erythema | 52.9 (41.8 to 63.9) | 50.0 (38.7 to 61.3) |
| Injection site pain | 74.1 (63.5 to 83.0) | 56.1 (44.7 to 67.0) |
| Injection site swelling | 52.9 (41.8 to 63.9) | 40.2 (29.6 to 51.7) |
Solicited systemic AE are predefined systemic events for which the participant's legally authorized representative was specifically questioned. Participant's legally acceptable representative used a VRC to report the following solicited systemic AEs: vomiting, drowsiness (somnolence), loss of appetite, and irritability. 95% CIs were calculated based on the exact binomial method proposed by Clopper and Pearson.
| Percentage of participants | Group 1: V, V, V | Group 2: H, H, V |
|---|---|---|
| Decreased appetite | 43.5 (32.8 to 54.7) | 36.6 (26.2 to 48.0) |
| Irritability | 77.6 (67.3 to 86.0) | 58.5 (47.1 to 69.3) |
| Somnolence | 64.7 (53.6 to 74.8) | 47.6 (36.4 to 58.9) |
| Vomiting | 3.5 (0.7 to 10.0) | 8.5 (3.5 to 16.8) |
An unsolicited AE is an AE that was not solicited using a VRC and that is communicated by a participant's legally authorized representative who has signed the informed consent. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. 95% CIs were calculated based on the exact binomial method proposed by Clopper and Pearson.
| Percentage of participants | Group 1: V, V, V | Group 2: H, H, V |
|---|---|---|
| Percentage of Participants With Unsolicited AEs | 97.6 (91.8 to 99.7) | 92.7 (84.8 to 97.3) |
An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is another important medical event. 95% CIs were calculated based on the exact binomial method proposed by Clopper and Pearson.
| Percentage of participants | Group 1: V, V, V | Group 2: H, H, V |
|---|---|---|
| Percentage of Participants With a Serious AE (SAE) | 0.0 (0.0 to 4.2) | 1.2 (0.0 to 6.6) |
Human antibodies to diphtheria toxoid were quantified using the Meso Scale Discovery Electrochemiluminescence serological assay based on an established reference standard sample curve with the lower limit of quantitation (LLOQ) for diphtheria antibody of 0.005 IU/mL. The percentage of participants with diphtheria toxoid antibodies ≥0.1 international units per milliliter (IU/mL) one month after Vaxelis™ as the 3rd dose of a vaccination series is presented. The 95% CIs are based on the exact binomial method proposed by Clopper and Pearson.
| Percentage of participants | Group 1: V, V, V | Group 2: H, H, V |
|---|---|---|
| Percentage of Participants With Diphtheria Toxoid Antibodies ≥0.1 IU/mL | 100.0 (94.8 to 100.0) | 98.6 (92.7 to 100.0) |
Human antibodies to tetanus toxoid were quantified using the Meso Scale Discovery Electrochemiluminescence serological assay based on an established reference standard sample curve with a LLOQ for tetanus antibody of 0.01 IU/mL. The percentage of participants with tetanus toxoid antibodies ≥0.1 IU/mL one month after Vaxelis™ as the 3rd dose of a vaccination series is presented. The 95% CIs are based on the exact binomial method proposed by Clopper and Pearson.
| Percentage of participants | Group 1: V, V, V | Group 2: H, H, V |
|---|---|---|
| Percentage of Participants With Tetanus Toxoid Antibodies ≥0.1 IU/mL | 98.6 (92.2 to 100.0) | 98.6 (92.7 to 100.0) |
Human antibodies to pertussis toxoid were quantified using the Meso Scale Discovery Electrochemiluminescence serological assay based on an established reference standard sample curve with a LLOQ for pertussis antibody of 2.00 EU/mL. The percentage of participants meeting response criteria for PT is based on pre-vaccination level of PT is presented. The 95% CIs are based on the exact binomial method proposed by Clopper and Pearson.
| Percentage of participants | Group 1: V, V, V | Group 2: H, H, V |
|---|---|---|
| Percentage of Participants With Pertussis Toxoid (PT) Vaccine Response | 98.4 (91.6 to 100.0) | 94.4 (86.2 to 98.4) |
Human antibodies to FHA were quantified using the Meso Scale Discovery Electrochemiluminescence serological assay based on an established reference standard sample curve with a LLOQ for FHA antibody of 2.00 EU/mL. The percentage of participants meeting response criteria for FHA response will be based on pre-vaccination level of FHA. The 95% CIs are based on the exact binomial method proposed by Clopper and Pearson.
| Percentage of participants | Group 1: V, V, V | Group 2: H, H, V |
|---|---|---|
| Percentage of Participants With Filamentous Hemagglutinin (FHA) Vaccine Response | 98.4 (91.6 to 100.0) | 90.1 (80.7 to 95.9) |
Human antibodies to Hib-PRP were quantified using the Vacczyme™ Human Anti-Haemophilus influenzae Type b Enzyme Immunoassay Kit. Levels of anti-Hib IgG were quantified by interpolation from a standard curve that has been calibrated to the FDA lot 1983 reference serum. The percentage of participants with Hib-PRP antibodies ≥0.1 IU/mL one month after Vaxelis™ as the 3rd dose of a vaccination series is presented. The 95% CIs are based on the exact binomial method proposed by Clopper and Pearson.
| Percentage of participants | Group 1: V, V, V | Group 2: H, H, V |
|---|---|---|
| Percentage of Participants With Haemophilus Influenzae Type b Polyribosylribitol Phosphate (Hib-PRP) Antibodies ≥1.0 µg/mL | 89.0 (79.5 to 95.1) | 90.8 (81.9 to 96.2) |
Human antibodies to HBsAg were quantified using an Enhanced Chemiluminescence (ECi) assay, with the hepatitis B WHO International reference standard at 10 mIU/mL as a control in every assay, and the LLOQ of the assay is 5 mIU/mL. The percentage of participants with HBsAg antibodies ≥10 milli-international per liter (mIU/mL) one month after Vaxelis™ as the 3rd dose of a vaccination series is presented. The 95% CIs are based on the exact binomial method proposed by Clopper and Pearson.
| Percentage of participants | Group 1: V, V, V | Group 2: H, H, V |
|---|---|---|
| Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Antibodies ≥10 mIU/mL | 100.0 (93.6 to 100.0) | 94.2 (85.8 to 98.4) |
Human antibodies to poliovirus serotype 1 were quantified with a neutralization assay by utilizing Vero cells and wild type poliovirus strain 1 as the challenge virus. The Karber method was used to determine the serum dilution that neutralized 50% of the challenge virus, with results expressed as titers (1:dilution), and the LLOQ was 1:4. dilution. The percentage of participants with poliovirus serotype 1 Nab ≥1:8 dilution one month after Vaxelis™ as the 3rd dose of a vaccination series is presented. The 95% CIs are based on the exact binomial method proposed by Clopper and Pearson.
| Percentage of participants | Group 1: V, V, V | Group 2: H, H, V |
|---|---|---|
| Percentage of Participants With Poliovirus Serotype 1 Neutralizing Antibodies (Nab) ≥1:8 Dilution | 100.0 (94.6 to 100.0) | 95.7 (87.8 to 99.1) |
Human antibodies to poliovirus serotype 2 were quantified with a neutralization assay by utilizing Vero cells and wild type poliovirus strain 2 as the challenge virus. The Karber method was used to determine the serum dilution that neutralized 50% of the challenge virus, with results expressed as titers (1:dilution), and the LLOQ was 1:4. dilution. The percentage of participants with poliovirus serotype 2 Nab ≥1:8 dilution one month after Vaxelis™ as the 3rd dose of a vaccination series is presented. The 95% CIs are based on the exact binomial method proposed by Clopper and Pearson.
| Percentage of participants | Group 1: V, V, V | Group 2: H, H, V |
|---|---|---|
| Percentage of Participants With Poliovirus Serotype 2 Neutralizing Antibodies (Nab) ≥1:8 Dilution | 100.0 (94.6 to 100.0) | 100.0 (94.8 to 100.0) |
Human antibodies to poliovirus serotype 3 were quantified with a neutralization assay by utilizing Vero cells and wild type poliovirus strain 3 as the challenge virus. The Karber method was used to determine the serum dilution that neutralized 50% of the challenge virus, with results expressed as titers (1:dilution), and the LLOQ was 1:4. dilution. The percentage of participants with poliovirus serotype 3 Nab ≥1:8 dilution one month after Vaxelis™ as the 3rd dose of a vaccination series is presented. The 95% CIs are based on the exact binomial method proposed by Clopper and Pearson.
| Percentage of participants | Group 1: V, V, V | Group 2: H, H, V |
|---|---|---|
| Percentage of Participants With Poliovirus Serotype 3 Neutralizing Antibodies (Nab) ≥1:8 Dilution | 97.0 (89.5 to 99.6) | 100.0 (94.8 to 100.0) |
Human antibodies to PRN were quantified using the Meso Scale Discovery Electrochemiluminescence serological assay based on an established reference standard sample curve with a LLOQ for PRN of 2.00 EU/mL.The percentage of participants meeting response criteria for PRN was based on pre-vaccination level of PRN. The 95% CIs are based on the exact binomial method proposed by Clopper and Pearson.
| Percentage of participants | Group 1: V, V, V | Group 2: H, H, V |
|---|---|---|
| Percentage of Participants With Pertactin (PRN) Vaccine Response | 92.2 (82.7 to 97.4) | 22.5 (13.5 to 34.0) |
Human antibodies to FIM 2/3 were quantified using the Meso Scale Discovery Electrochemiluminescence serological assay based on an established reference standard sample curve with a LLOQ for pertussis antibody of 2.00 EU/mL. The percentage of participants meeting response criteria for FIM 2/3 was based on pre-vaccination level of FIM 2/3. The 95% CIs are based on the exact binomial method proposed by Clopper and Pearson.
| Percentage of participants | Group 1: V, V, V | Group 2: H, H, V |
|---|---|---|
| Percentage of Participants With Fimbriae 2/3 (FIM 2/3) Vaccine Response | 95.3 (86.9 to 99.0) | 69.0 (56.9 to 79.5) |
Collected over Adverse events (AEs): from vaccination up to 40 days post-vaccination; All-cause mortality (ACM): From allocation up to 40 days post-vaccination. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Group 1: V, V, V | 0/86 (0%) | 0/85 (0%) | 83/85 (97.6%) |
| Group 2: H, H, V | 0/82 (0%) | 1/82 (1.2%) | 75/82 (91.5%) |
| Event | Group 1: V, V, V | Group 2: H, H, V |
|---|---|---|
| Gastroenteritis adenovirusInfections and infestations | 0/85 | 1/82 |
| Event | Group 1: V, V, V | Group 2: H, H, V |
|---|---|---|
| IrritabilityPsychiatric disorders | 66/85 | 48/82 |
| Injection site painGeneral disorders | 63/85 | 46/82 |
| SomnolenceNervous system disorders | 55/85 | 39/82 |
| Injection site erythemaGeneral disorders | 45/85 | 41/82 |
| Injection site swellingGeneral disorders | 45/85 | 33/82 |
| PyrexiaGeneral disorders | 34/85 | 40/82 |
| Decreased appetiteMetabolism and nutrition disorders | 37/85 | 30/82 |
| VomitingGastrointestinal disorders | 5/85 | 8/82 |
| DiarrhoeaGastrointestinal disorders | 1/85 | 6/82 |
| Injection site indurationGeneral disorders | 0/85 | 6/82 |
| Age, Continuous(Days) | Group 1: V, V, V | Group 2: H, H, V | Total |
|---|---|---|---|
| Mean | 348.8 ± 18.8 | 344.7 ± 16.4 | 346.8 ± 17.7 |
| Sex: Female, Male(Participants) | Group 1: V, V, V | Group 2: H, H, V | Total |
|---|---|---|---|
| Female | 44 | 33 | 77 |
| Male | 42 | 49 | 91 |
| Ethnicity (NIH/OMB)(Participants) | Group 1: V, V, V | Group 2: H, H, V | Total |
|---|---|---|---|
| Hispanic or Latino | 45 | 60 | 105 |
| Not Hispanic or Latino | 34 | 21 | 55 |
| Unknown or Not Reported | 7 | 1 | 8 |
| Race (NIH/OMB)(Participants) | Group 1: V, V, V | Group 2: H, H, V | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 85 | 82 | 167 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Merck Sharp & Dohme LLC